NCT01245751

Brief Summary

This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2011

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 29, 2013

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

April 12, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

November 19, 2010

Results QC Date

April 10, 2013

Last Update Submit

March 15, 2017

Conditions

Herpes ZosterVaricella-zoster Vaccine

Keywords

ShinglesVaccine

Outcome Measures

Primary Outcomes (2)

  • Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)

    VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)

    Day 1 (Baseline) and Week 6 postvaccination

  • Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers

    VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.

    Day 1 (Baseline) and Week 6 postvaccination

Secondary Outcomes (1)

  • Number of Participants Reporting One or More Adverse Experiences

    Up to 42 days postvaccination

Study Arms (4)

Group 1: Booster Dose Participants ≥70 years of age

EXPERIMENTAL

Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 NCT00007501)

Biological: Zoster Vaccine, Live

Group 2: First Dose Participants ≥70 years of age

EXPERIMENTAL

Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age

Biological: Zoster Vaccine, Live

Group 3: First Dose Participants ≥60 and <70 years of age

EXPERIMENTAL

Herpes zoster history-negative participants ≥60 and \<70 years of age who have never received Zoster Vaccine, Live

Biological: Zoster Vaccine, Live

Group 4: First Dose Participants ≥50 and <60 years of age

EXPERIMENTAL

Herpes zoster history-negative participants ≥50 and \<60 years of age who have never received Zoster Vaccine, Live

Biological: Zoster Vaccine, Live

Interventions

Zoster Vaccine, LiveBIOLOGICAL

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Also known as: V211, ZOSTAVAX™
Group 1: Booster Dose Participants ≥70 years of ageGroup 2: First Dose Participants ≥70 years of ageGroup 3: First Dose Participants ≥60 and <70 years of ageGroup 4: First Dose Participants ≥50 and <60 years of age

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All Groups:
  • Must not have a fever of ≥100.4° F on the day of vaccination
  • Any underlying chronic illness must be in stable condition
  • History of varicella or residence in a VZV-endemic area for ≥30 years
  • Group 1:
  • years of age or older
  • Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study
  • Group 2:
  • years of age or older
  • Group 3:
  • to 69 years of age
  • Group 4:
  • to 59 years of age

You may not qualify if:

  • All Groups:
  • History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin
  • Prior history of herpes zoster
  • Pregnant or breast-feeding, or expecting to conceive within the duration of the study
  • Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination
  • Received any other vaccine within 4 weeks prevaccination
  • On immunosuppressive therapy
  • Has known or suspected immune dysfunction
  • Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.
  • Groups 2, 3, and 4:
  • Has previously received any varicella or zoster vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Levin MJ, Schmader KE, Pang L, Williams-Diaz A, Zerbe G, Canniff J, Johnson MJ, Caldas Y, Cho A, Lang N, Su SC, Parrino J, Popmihajlov Z, Weinberg A. Cellular and Humoral Responses to a Second Dose of Herpes Zoster Vaccine Administered 10 Years After the First Dose Among Older Adults. J Infect Dis. 2016 Jan 1;213(1):14-22. doi: 10.1093/infdis/jiv480. Epub 2015 Oct 9.

    PMID: 26452397RESULT

  • Weinberg A, Popmihajlov Z, Schmader KE, Johnson MJ, Caldas Y, Salazar AT, Canniff J, McCarson BJ, Martin J, Pang L, Levin MJ. Persistence of Varicella-Zoster Virus Cell-Mediated Immunity After the Administration of a Second Dose of Live Herpes Zoster Vaccine. J Infect Dis. 2019 Jan 7;219(2):335-338. doi: 10.1093/infdis/jiy514.

    PMID: 30165651DERIVED

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 22, 2010

Study Start

April 1, 2011

Primary Completion

July 1, 2012

Study Completion

May 1, 2015

Last Updated

April 12, 2017

Results First Posted

May 29, 2013

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php